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13,326 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
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13,326 catalysts · 3,350 8k filing · 2,401 grant · 2,076 approval · 1,436 device 510k · 1,072 device recall · 1,000 device adverse event
Product code: SFL. Advisory committee: MG. Decision: APPR
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — Reason: Product testing did not meet expected stability criteria. — Status: Ongoing
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System — Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. — Status: Ongoing
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: PHATHOM. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: STERISCIENCE. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: QAS. Advisory committee: Radiology. Type: Special
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: HBL. Advisory committee: Neurology. Type: Traditional
Product code: DXX. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HBE. Advisory committee: Neurology. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NGV. Advisory committee: CV. Decision: APPR
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) — Reason: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome. — Status: Ongoing
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 — Reason: Labeling discrepancy; Ureteral stent actual size may not match the actual product label. — Status: Ongoing